COOK ENDOSCOPY PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL; KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
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Catalog Number PEG-24-PULL-I-S |
Device Problem
Positioning Problem (3009)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Investigation evaluation: the investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report with further information.
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Event Description
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During a percutaneous endoscopic gastrostomy (peg), the physician used a cook peg 24 percutaneous endoscopic gastrostomy set - pull.The wire loop attached to the dilator on the silicone tube broke after a lot of force was applied to pull the tube through the abdominal wall.This happened on three (3) separate occasions with three (3) separate devices and patients (subject of this report, and see related mdr 1037905-2019-00197 and mdr 1037905-2019-00198).The nurse saw one case and commented that the force used to pull the tube through was unusually excessive.Additional information was received on 03-apr-2019: when pulling the tube through the abdominal wall, excessive force was used/required and the loop broke.The physician felt that the force to pass the tubes was more than normally required, but the clinician was a trainee, so [they had] limited experience.The consultant in attendance thought it was excessive as did the nurses.The feeding tubes were difficult to pass through the incision but not sure why.No sections of the devices remained inside the patient¿s bodies.The patients did not require any additional procedures due to this occurrence.According to the initial reporter, the patients did not experience any adverse effects due to this occurrence.
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Manufacturer Narrative
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Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.Prior to distribution, all peg 24 percutaneous endoscopic gastrostomy sets - pull are subjected to a visual inspection to ensure device integrity.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
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Event Description
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During a percutaneous endoscopic gastrostomy (peg), the physician used a cook peg 24 percutaneous endoscopic gastrostomy set - pull.The wire loop attached to the dilator on the silicone tube broke after a lot of force was applied to pull the tube through the abdominal wall.This happened on three (3) separate occasions with three (3) separate devices and patients (subject of this report, and see related mdr 1037905-2019-00197 and mdr 1037905-2019-00198).The nurse saw one case and commented that the force used to pull the tube through was unusually excessive.Additional information was received on 03-apr-2019: when pulling the tube through the abdominal wall, excessive force was used/required and the loop broke.The physician felt that the force to pass the tubes was more than normally required, but the clinician was a trainee, so [they had] limited experience.The consultant in attendance thought it was excessive as did the nurses.The feeding tubes were difficult to pass through the incision but not sure why.No sections of the devices remained inside the patient¿s bodies.The patients did not require any additional procedures due to this occurrence.According to the initial reporter, the patients did not experience any adverse effects due to this occurrence.
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Search Alerts/Recalls
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